Responsibilities:
- Maintain knowledge of local legislation and Health Authority requirements; keep WWOO leadership informed of updates/changes.
- Track local process status, changes, and risks; support consistency and continuous improvement using common tools.
- Develop innovative approaches to core PV activities, including integration of new technologies (e.g., AI).
- Ensure country compliance with the global PV quality system; support inspections, audits, CAPAs, and timely resolution of deviations/non-compliance.
- Serve as local safety point of contact (PoC) and coordinate with global GPS teams (e.g., PV Enablement, CER, SS) and non-GPS teams (e.g., Med Affairs, Regulatory).
- Guide global teams on local requirements and ensure compliance with local legislation.
- Coordinate with other PV hub(s) as needed for local documentation and contributions.
- Shape compliant programs producing high-quality adverse event reports.
- Build, coach, and scale a high-performing team; drive succession planning and talent pipelines.
Qualifications:
- Minimum Bachelorโs Degree (Advanced Degree preferred) with 12+ years PV experience and demonstrated achievements in patient safety.
- Experience supporting regulatory inspections, audits, and country/regional quality issue management.
- Preferred: AI technology experience.
- Ability to coordinate across functions/cultures as an execution and escalation lead.
- Strong organizational and communication skills; ability to surface risks early and drive resolution via global governance.